An Investigational Scan (rh PSMA 7.3 PET/MRI) for the Detection of Recurrent Disease and Aid in Radiotherapy Planning in Biochemically Recurrent Prostate Cancer

A Prospective Pilot Study Investigating rhPSMA 7.3 PET/MRI in Detecting Recurrent Disease and Aid in Radiotherapy Planning in Patients With Biochemically Recurrent Prostate Cancer

This prospective pilot study will assess the feasibility of rh PSMA 7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) scans in detecting prostate cancer that may have come back (recurrent) in patients with increasing levels of prostate-specific antigen (PSA) following prostate surgery (biochemically recurrent). An increase in PSA levels alone does not tell the doctor where the cancer may be or how much cancer there may be. Imaging tests, like a bone scan, MRI, and/or computed tomography, are often performed to help the doctor learn where or how much cancer there is, and how best to treat the cancer. rhPSMA-7.3 is a radioactive tracer agent that when used with PET/MRI imaging may help diagnose and look for the spread of prostate cancer. Prostate-specific membrane antigen (PSMA) is a protein that is expressed in prostate cancer and this agent targets the PSMA molecule. Giving rh PSMA 7.3 during PET/MRI may help doctors better find where the cancer may be spreading and how much of it there is. The results of this trial may also guide in radiotherapy planning.

Study Overview

• Status: Recruiting
• Conditions: Biochemically Recurrent Prostate Carcinoma; Prostate Adenocarcinoma; Localized Prostate Carcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Drug: Fluorine F 18 rhPSMA-7.3

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the positive predictive value and detection rate of fluorine F 18 rhPSMA-7.3 (F-18 rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance imaging (MRI) in detecting recurrent disease in prostate cancer patients with biochemical recurrence.

SECONDARY OBJECTIVE:

I. To determine the change in salvage radiation treatment plan after F-18 rhPSMA-7.3 PET/MRI imaging.

EXPLORATORY OBJECTIVES:

I. To assess the feasibility of utilizing the PSMA avid recurrent disease on PET/MRI as an alignment tool for MR guided radiotherapy (MR linear accelerator [MR-LINAC]).

II. To assess the treatment response in those patients who demonstrate rhPSMA-7.3 avid disease on the first PET/MRI scan.

OUTLINE:

Patients receive F-18 rhPSMA-7.3 intravenously (IV) and after approximately 60 minutes of uptake time, will undergo PET/MRI over 60 minutes. Patients with evidence of F-18 rhPSMA-7.3 disease in the first PET/MRI scan undergo a second F-18 rhPSMA-7.3 PET/MRI at 6 months after the second dose of standard hormonal therapy.

After completion of study treatment, patients are followed up within 7 days.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Devaki Shilpa S. Surasi; Phone Number: 713-792-6536; Email: dssurasi@mdanderson.org
      • Principal Investigator: Devaki Shilpa S. Surasi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is male and aged > 18 years old
• History of localized adenocarcinoma of the prostate status post (s/p) radical prostatectomy
• An initial elevated PSA >= 0.2 followed by a subsequent confirmatory PSA >= 0.2 clinically suspicious for biochemically recurrent disease
• If the patients were previously taking androgen deprivation therapy (ADT), it should be discontinued at least 12 weeks prior to the study
• Treatment plan includes salvage radiation with or without hormones.
• Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible
• Non-English speaking patients may be enrolled.

Exclusion Criteria:

• Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements
• Patients who are planned to have an Iodinated contrast agent with computed tomography (CT) or gadolinium based contrast agent with MRI or other PET radiotracer < 24 hours prior to the PET scan
• Patients with contraindication to undergo MRI
• Patients with extreme claustrophobia
• Patients with prior allergy to MRI contrast agent
• Patients who are cognitively impaired

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (F-18 rhPSMA-7.3, PET/MRI); Patients receive F-18 rhPSMA-7.3 IV and after approximately 60 minutes of uptake time, will undergo PET/MRI over 60 minutes. Patients with evidence of F-18 rhPSMA-7.3 disease in the first PET/MRI scan undergo a second F-18 rhPSMA-7.3 PET/MRI at 6 months after the second dose of standard hormonal therapy.

Procedure: Magnetic Resonance Imaging; Undergo PET/MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Undergo PET/MRI; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; Drug: Fluorine F 18 rhPSMA-7.3; Given IV; Other Names: 18F-rhPSMA-7.3; rhPSMA-7.3 (18F); (18F)-rhPSMA-7.3; 18FrhPSMA-7.3; F-18-rhPSMA-7.3; Fluorine F 18 radiohybrid PSMA-7.3; Fluorine-18 rhPSMA-7.3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value (PPV) of F-18 rhPSMA-7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) in detecting recurrent disease	Will be evaluated on both a per-patient and per-region basis. Will estimate the PPV rate and corresponding 95% confidence interval.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate	Defined as the proportion of patients with prostate-specific membrane antigen (PSMA) positive results. The association between detection and prostate specific antigen level will be assessed by Wilcoxon rank-sum tests.	Up to 6 months
Change in salvage radiation treatment plan	The proportion of patients with major and minor changes will be summarized.	Baseline up to 6 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Devaki Shilpa S Surasi, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Estimated): April 28, 2024
• Study Completion (Estimated): April 28, 2024

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Carcinoma; Recurrence; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 2020-1347 (Other Identifier: M D Anderson Cancer Center); NCI-2021-05725 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No